2024
A Phase III, Randomized Study of Daratumumab, Cyclophosphamide, Bortezomib and Dexamethasone (DARA-VCD) Induction Followed By Autologous Stem Cell Transplant or Dara-VCD Consolidation and Daratumumab Maintenance in Patients with Newly Diagnosed AL Amyloidosis
Hagen P, Sidana S, Parker T, Walker B, Sanchorawala V, Zonder J, Kourelis T, D'Souza A, Landau H, Rosenthal A, Hoering A, Ailawadhi S, Orlowski R. A Phase III, Randomized Study of Daratumumab, Cyclophosphamide, Bortezomib and Dexamethasone (DARA-VCD) Induction Followed By Autologous Stem Cell Transplant or Dara-VCD Consolidation and Daratumumab Maintenance in Patients with Newly Diagnosed AL Amyloidosis. Blood 2024, 144: 3309.1-3309.1. DOI: 10.1182/blood-2024-208227.Peer-Reviewed Original ResearchAutologous stem cell transplantationNext generation flow cytometryStem cell transplantationOverall survivalConsolidation therapyAL amyloidCell transplantationASCT armLight chain (AL) amyloidosisSeverity of cardiac involvementFlow cytometryAL amyloid patientsDaratumumab to bortezomibTransplant related mortalityProgression free survivalHematologic response rateTwo-sided significance levelPlasma cell malignancyMulti-organ involvementDaratumumab maintenanceInduction therapyMRD negativityFree survivalIntergroup trialCardiac involvementIsatuximab in Relapsed AL Amyloidosis: Results of a Prospective Phase II Trial (SWOG S1702)
Parker T, Rosenthal A, Sanchorawala V, Landau H, Campagnaro E, Kapoor P, Neparidze N, Girnius S, Hagen P, Scott E, Hoering A, Durie B, Orlowski R. Isatuximab in Relapsed AL Amyloidosis: Results of a Prospective Phase II Trial (SWOG S1702). Blood 2024, 144: 3378-3378. DOI: 10.1182/blood-2024-208341.Peer-Reviewed Original ResearchMedian time to responseRelapsed AL amyloidosisTime to responseAL amyloidosisPartial responseHematologic responseComplete responseCardiac involvementOverall survivalRenal involvementOrgan involvementEastern Cooperative Oncology Group performance statusRate of hematologic responseAutologous stem cell transplantationProspective phase II trialLight chain (AL) amyloidosisDistribution of organ involvementProgression free survivalHematologic complete responseHematologic response rateStem cell transplantationPhase II trialAnti-CD38 antibodiesSystemic AL amyloidosisRate of patientsA phase III, randomized study of daratumumab, cyclophosphamide, bortezomib and dexamethasone (DARA-VCD) induction followed by autologous stem cell transplant or DARA-VCD consolidation and daratumumab maintenance in patients with newly diagnosed AL amyloidosis.
Hagen P, Sidana S, Parker T, Walker B, Hoering A, Sanchorawala V, Zonder J, Kourelis T, D'Souza A, Landau H, Rosenthal A, Ailawadhi S, Orlowski R. A phase III, randomized study of daratumumab, cyclophosphamide, bortezomib and dexamethasone (DARA-VCD) induction followed by autologous stem cell transplant or DARA-VCD consolidation and daratumumab maintenance in patients with newly diagnosed AL amyloidosis. Journal Of Clinical Oncology 2024, 42: tps7575-tps7575. DOI: 10.1200/jco.2024.42.16_suppl.tps7575.Peer-Reviewed Original ResearchAutologous stem cell transplantationProgression free survivalStem cell transplantationOverall survivalCell transplantationASCT armNext generation flow cytometryLight chain (AL) amyloidosisDaratumumab to bortezomibDiagnosed AL amyloidosisTwo-sided significance levelPlasma cell malignancyShort follow-upDaratumumab maintenanceMRD negativityFree survivalInduction therapyIntergroup trialMultiple myelomaAL amyloidosisHematologic responseRenal responseRandomized studyCell malignancyFollow-up
2021
Outcomes Among Primary Refractory Multiple Myeloma Patients in the Era of Monoclonal Antibodies: The Yale Experience
Liu Y, Kywe B, Crawford L, Lora F, Bar N, Browning S, Gorshein E, Parker T, Neparidze N. Outcomes Among Primary Refractory Multiple Myeloma Patients in the Era of Monoclonal Antibodies: The Yale Experience. Blood 2021, 138: 1635. DOI: 10.1182/blood-2021-146619.Peer-Reviewed Original ResearchAutologous stem cell transplantMedian overall survivalInternational Staging System stage IIRefractory multiple myeloma patientsOverall survivalMultiple myeloma patientsMultiple myelomaInduction therapyPartial responsePrimary refractoryInduction regimenMyeloma patientsMonoclonal antibodiesPlasma cellsInternational Myeloma Working Group criteriaYale New Haven Health SystemStage IIHigh-risk cytogeneticsGood partial responseRetrospective cohort studyMajority of patientsMRD-negative statusMonoclonal antibody therapyStem cell transplantImportant prognostic value
2020
Carfilzomib or bortezomib in combination with lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma without intention for immediate autologous stem-cell transplantation (ENDURANCE): a multicentre, open-label, phase 3, randomised, controlled trial
Kumar SK, Jacobus SJ, Cohen AD, Weiss M, Callander N, Singh AK, Parker TL, Menter A, Yang X, Parsons B, Kumar P, Kapoor P, Rosenberg A, Zonder JA, Faber E, Lonial S, Anderson KC, Richardson PG, Orlowski RZ, Wagner LI, Rajkumar SV. Carfilzomib or bortezomib in combination with lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma without intention for immediate autologous stem-cell transplantation (ENDURANCE): a multicentre, open-label, phase 3, randomised, controlled trial. The Lancet Oncology 2020, 21: 1317-1330. PMID: 32866432, PMCID: PMC7591827, DOI: 10.1016/s1470-2045(20)30452-6.Peer-Reviewed Original ResearchConceptsAutologous stem cell transplantationProgression-free survivalStem cell transplantationVRd regimenInduction therapyMultiple myelomaVRd groupDay 1Oral lenalidomideOral dexamethasoneOverall survivalEastern Cooperative Oncology Group performance statusMedian progression-free survivalNon-haematological adverse eventsSecond planned interim analysisNext-generation proteasome inhibitorsHigh-risk multiple myelomaCommon grade 3Treatment-related deathsMedian overall survivalPhase 2 trialCommunity oncology practicesStandard of careKey inclusion criteriaPhase 3